Simple instruments, such as scalpels and scissors, have been used throughout the history of medicine for cutting tissue. Other cutting devices have been developed for manually cutting or slicing tissue or for more automated cuts (e.g., circular blades for end-to-end anastomotic staplers) or even lasers for cutting tissue structures using electromagnetic energy. However, such cutting devices have not provided a simple, precise way of accurately guiding a cutting blade at remote structures. Guide wires are used in many medical techniques. For example, a cautery wire on a balloon is used to burn through tissue, such as in a product called Acucise® (sold by Applied Medical Resources Corp. of Rancho Santa Margarita, Calif.). This balloon device's use of electrocautery to burn open wounds is sometimes contraindicated for optimized wound healing; it is also somewhat cumbersome to use and is quite expensive. While such devices may be useful in their particular applications, they do not generally control for the precise, optimized cutting of tissue at a remote site utilizing a blade that can be guided along the intended path with accuracy and control.
A disease process of often unclear etiology can occur in patients at the junction of the ureter and the renal pelvis, (i.e., commonly called the UPJ) leading to the narrowing of the proximal ureter and causing an obstruction of urine flow out of the renal pelvis. Such urinary flow obstruction can cause a painful disease state, called hydronephrosis. Varying degrees of relief for this pathologic process can be realized through surgery using longitudinal incisions in the ureteral wall through the length of the stricture or cutting the entire diseased section away and suturing the ureter back onto the renal pelvis. Completely transecting the ureter off of the renal pelvis and surgically reattaching it using sutures is a procedure called amputation pyeloplasty; this amputation pyeloplasty approach usually requires a sophisticated, major open operation. A less invasive, alternative method is to create a longitudinal oriented incision in the narrowed ureter to relieve the obstruction and it can be further enhanced by a suture closure of the longitudinal incision in a transverse fashion. This longitudinal to transverse wound closure approach is often called a Heineke-Mikulicz technique and in the application of the sutured closure of the stenotic renal pelvis is called a Fenger-plasty. Leaving the ureteral incision unclosed (i.e., a pyelotomy) results in a 10% to 15% reduction in long-term relief of the obstructive symptoms when compared to a sutured closure (i.e., a pyeloplasty). The Acucise® balloon may be used for simply cutting open the ureter for a pyelotomy. Research has been conducted toward improving suturing such wound closures together using automated suturing technologies. The SEW-RIGHT® SR 5® (SEW-RIGHT® produced by LSI SOLUTIONS, Inc., Victor, N.Y.) in a pre-clinical porcine model is described in the Journal of Endourology (Desai M M, Gill I S, Carvalhal E F, Kaouk J H, Banks K, Raju R, Raja S S, Meraney A M, Sung G T, Sauer J S: Percutaneous Endopyeloplasty: A Novel Technique. Volume 16, Number 7, September 2002, Pages 431-443). Subsequent clinical applications of this suturing approach were published in the Journal of Urology (Gill I S, Desai M M, Kaouk J H, Wani K, Desai M R: Percutaneous Endopyeloplasty: Description of a New Technique. Volume 168, Number 5, November 2002, Pages 2097-2102). As a result of this research, it became evident of a need for improved incising these openings in the strictured ureters, which can also be used in other tubular tissue structures.